BioCentury This Week Ep. 314 - Prasad, Lilly Obesity, Acadia & Biosecure
Aug 12, 2025
Lilly's oral obesity drug, orforglipron, sparks debate despite disappointing Phase III results, with a safety edge over injectables. Vinay Prasad’s return to the FDA prompts discussions on regulatory reform amid industry confusion. Acadia Pharmaceuticals is revamping its strategy to tackle challenges in the neurology sector. Meanwhile, the Senate aims to revive the Biosecure Act, raising concerns about fairness for biotech firms. Finally, a reimagined vision for the FDA promises innovative solutions for the future of drug regulation.
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Small Molecule Manufacturing Edge
- Stephen Hansen highlights Lilly's small molecule advantage for scaling and lower COGS.
- Small-molecule orals can meet demand more easily than peptide oral alternatives.
Better Tolerability And No Liver Signal
- [Orforglipron] showed numerically better GI tolerability than semaglutide in the phase three setting.
- The program also showed no liver toxicity signal, easing a common small-molecule worry.
Investor Expectations Inflated Valuations
- Stephen says sell-side models pushed orforglipron to $40–50B peak sales assumptions.
- The phase three readout forced analysts to cut forecasts and investor sentiment.